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    Summary
    EudraCT Number:2007-002104-18
    Sponsor's Protocol Code Number:GID25
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2007-002104-18
    A.3Full title of the trial
    Evaluation of the Cellular, Humoral and Mucosal Immune Response in Adults and Elderly Subjects Vaccinated either with an Inactivated Influenza Vaccine Administered via the Intradermal Route or an Inactivated Influenza Vaccine Administered via the Intramuscular Route
    A.4.1Sponsor's protocol code numberGID25
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi Pasteur SA
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIntradermal Influenza Vaccine
    D.3.2Product code 333
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInactivated, split-virion, influenza virus (H3N2 strain)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number90
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInactivated, split-virion, influenza virus (H1N1 strain)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number90
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInactivated, split-virion, influenza virus (B strain)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIntradermal Influenza Vaccine
    D.3.2Product code 333
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInactivated, split-virion, influenza virus (H3N2 strain)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInactivated, split-virion, influenza virus (H1N1 strain)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInactivated, split-virion, influenza virus (B strain)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name VAXIGRIP
    D.2.1.1.2Name of the Marketing Authorisation holderFRANCE SANOFI PASTEUR S.A.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInactivated, split-virion, influenza virus (H3N2 strain)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInactivated, split-virion, influenza virus (H1N1 strain)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInactivated, split-virion, influenza virus (B strain)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vaccination of adult subjects aged 18 to 40 years and elderly subjects aged 60 to 85 years with an inactivated, split-virion influenza vaccine administered via the intradermal route using Vaxigrip® as IM reference vaccine
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To describe the cellular immune response per age group (adults or elderly) and vaccine group (ID influenza or IM comparator vaccines) before vaccination, and, 7 days, 10 days, 14 days, 21 days, 180 days after vaccination
    - To describe the humoral immune response per age group and vaccine group before vaccination, 14 days, 21 days, and 180 days after vaccination
    - To describe mucosal immunity per age group and vaccine group through quantification of influenza-specific IgA (total, specific and sub-classes: IgA1 and IgA2) collected from saliva and serum before vaccination and 10 days, 14 days, 21 days and 180 days after vaccination
    - To describe the safety of the vaccines per age group and per vaccine group after vaccination
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Aged 18 to 40 years (adults) or 60 to 85 years (elderly)
    2) Provision of a signed informed consent
    3) Able to attend all scheduled visits and comply with all trial procedures
    4) For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until 4 weeks after vaccination
    5) Entitlement to national social security
    E.4Principal exclusion criteria
    1) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test
    2) Breast-feeding woman
    3) Participation in another clinical trial investigating a vaccine, drug, medical device or a medical procedure in the 4 weeks preceding the trial vaccination
    4) Planned participation in another clinical trial during the present trial period
    5) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
    6) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
    7) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
    8) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
    9) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
    10) Receipt of any vaccine in the 4 weeks preceding the trial vaccination
    11) Planned receipt of any vaccine in the 4 weeks following the trial vaccination
    12) Known Human Immunodeficiency Virus, Hepatitis B or Hepatitis C seropositivity
    13) Previous vaccination against Influenza in the previous 6 months
    14) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding the inclusion contraindicating IM vaccination
    15) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
    16) Febrile illness (oral temperature ≥37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
    E.5 End points
    E.5.1Primary end point(s)
    Cellular Immune Response

    - Intracellular Cytokine Staining (ICS):
    -- To quantify the number of Interferon- γ (INF-γ), Interleukine-2 (IL-2) or Tumor necrosis factor- α (TNF-α) secreting CD4+ and CD8+ T lymphocytes after stimulation with influenza live virus (for each vaccine strain) in all the subjects at D0, D7, D10, D14, D21 and D180
    -- To quantify the number of influenza-specific CD4+ and CD8+ T lymphocytes displaying a memory profile (IL-2 secreting cells [IL-2+]) in all the subjects at D0, D7, D10, D14, D21 and D180
    -- To quantify the number of influenza-specific CD4+ and CD8+ T lymphocytes exhibiting an effector profile (INF-γ and TNF-α secreting cells [INF-γ+ and TNF-α+]) in all the subjects at D0, D7, D10, D14, D21 and D180

    - Cytometric Bead Array (CBA):
    -- To measure the concentration of a panel of Th1 (IFN-γ, TNF-α, IL-2), and Th2 (IL-5, IL-4, IL 10) cytokines secreted by peripheral blood mononuclear cells (PBMCs) upon in vitro re stimulation with the three influenza vaccine strains in all the subjects at D0 and at the peak of the cellular response measured by ICS (D7 or D10 or D14 or D21 or D180)

    - Lymphoproliferation:
    -- To quantify the specific lymphoproliferative response (measured by 3H-thymidine incorporated in cells and expressed in counts per minute [cpm]), upon in vitro re-stimulation of PBMCs (= Stimulation Index [SI]) with influenza antigens from the three vaccine strains in all the subjects at D0 and at the peak of the cellular response measured by ICS (D7 or D10 or D14 or D21 or D180)
    Depending on the results obtained with ICS method, CBA and lymphoproliferation assessments will not be performed at each timepoint: if a peak of response is clearly identified for one of the timepoints tested, CBA and lymphoproliferatrion methods will be performed at this timepoint only. If no peak of response emerged, CBA and lymphoproliferatrion method will be performed at the most relevant timepoint obtained according to results and literature.

    Humoral Immune Response

    The humoral immune response will be evaluated in all subjects using the hemagglutination inhibition (HI) test. Anti-hemagglutinin (HA) antibody titers for the three strains will be measured before vaccination and at 14, 21, and 180 days after vaccination.
    The endpoints per strain will be:
    -- Anti-HA individual titer on D0, D14, D21 and D180
    -- Individual titers ratio:, D14/D0, D21/D0 and D180/D0
    -- Seroconversion status (subjects with a pre-vaccination titer < 10 [1/dil], post-vaccination titer ≥40 [1/dil] on D14, D21 and D180), or significant increase of post-vaccination titer (subjects with a pre-vaccination titer ≥10 [1/dil], post-vaccination titer ≥ 4-fold increase versus pre- vaccination titer on D14, D21 and D180)
    --Seroprotection status: titer ≥40 (1/dil) on D14, D21 and D180
    Seroprotection and seroconversion will be described using the criteria of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.

    Mucosal Immunity

    Total IgA, specific IgA, IgA1 and IgA2, each from saliva and serum, will be measured using Enzyme-Like Immunsorbent Assay (ELISA) before vaccination and 10, 14, 21, and 180 days after vaccination.
    The endpoints will be:
    -- Individual titer - for saliva and serum - for Total IgA, Specific IgA, IgA1 and IgA2 on D0, D10, D14, D21 and D180
    -- Individual titer ratio - for saliva and serum - for Total IgA, Specific IgA, IgA1 and IgA2 on D10/D0, D14/D0, D21/D0 and D180/D0
    Individual titer ratio - for saliva and serum - Specific IgA / Total IgA on D0, D10, D14, D21 and D180

    Safety

    The endpoints will be:
    -- Occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), duration, severity, and relationship to vaccination of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after vaccination
    -- Occurrence of the reactions (MedDRA Preferred Terms) as per the Committee for
    Human Medicinal Products (CHMP) NfG CPMP/BWP/214/96 in the 3 days
    following vaccination.
    -- Occurrence, time to onset, number of days of occurrence, and severity of solicited (prelisted in the subject’s diary card (DC) and the Case Report Form [CRF]) injection site and systemic reactions up to 7 days after vaccination
    -- Occurrence, nature (MedDRA preferred term), time to onset, duration, severity, and relationship to vaccination (for systemic AEs only) of unsolicited (spontaneously reported) AEs up to 21 days after vaccination
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity (in terms of cellular, humoral and mucosal immune responses)
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-05
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